From: Phase I clinical trial of a novel autologous modified-DC vaccine in patients with resected NSCLC
A | |||||||||
Adverse Event | Total, n (%) | ||||||||
N = 15 | |||||||||
 | Any Grade | Grade 1–2 | Grade 3–4 | ||||||
Pyrexia | 6 (40%) | 6 (40%) | 0 | ||||||
Fatigue | 5 (33.33%) | 5 (33.33%) | 0 | ||||||
Palpitate | 1 (6.67%) | 1 (6.67%) | 0 | ||||||
Headache | 3 (20%) | 3 (20%) | 0 | ||||||
Chest pain | 1 (6.67%) | 1 (6.67%) | 0 | ||||||
Chest Congestion | 1 (6.67%) | 1 (6.67%) | 0 | ||||||
Abdominal pain | 5 (33.33%) | 5 (33.33%) | 0 | ||||||
Abdominal distension | 2 (13.33%) | 2 (13.33%) | 0 | ||||||
Nausea | 3 (20%) | 3 (20%) | 0 | ||||||
Hypertension | 1 (6.67%) | 1 (6.67%) | 0 | ||||||
Nasal congestion | 1 (6.67%) | 1 (6.67%) | 0 | ||||||
CRP increased | 7 (46.67%) | 7 (46.67%) | 0 | ||||||
Myalgia | 6 (40%) | 6 (40%) | 0 | ||||||
Creatinine increased | 2 (13.33%) | 2 (13.33%) | 0 | ||||||
Chills | 1 (6.67%) | 1 (6.67%) | 0 | ||||||
B | |||||||||
Adverse Event | 1 × 106, n (%) | 1 × 107, n (%) | Maximum numbersof cultured cell, n (%) | ||||||
 | N = 3 | N = 3 | N = 9 | ||||||
 | Any Grade | Grade 1–2 | Grade 3–4 | Any Grade | Grade 1–2 | Grade 3–4 | Any Grade | Grade 1–2 | Grade 3–4 |
Pyrexia | 0 | 0 | 0 | 1 (33.33%) | 1 (33.33%) | 0 | 5 (55.56%) | 5 (55.56%) | 0 |
Fatigue | 1 (33.33%) | 1 (33.33%) | 0 | 1 (33.33%) | 1 (33.33%) | 0 | 3 (33.33%) | 3 (33.33%) | 0 |
Palpitate | 1 (33.33%) | 1 (33.33%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Headache | 1 (33.33%) | 1 (33.33%) | 0 | 1 (33.33%) | 1 (33.33%) | 0 | 1 (11.11%) | 1 (11.11%) | 0 |
Chest pain | 1 (33.33%) | 1 (33.33%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Chest Congestion | 1 (33.33%) | 1 (33.33%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Abdominal pain | 3 (100%) | 3 (100%) | 0 | 0 | 0 | 0 | 2 (22.22%) | 2 (22.22%) | 0 |
Abdominal distension | 0 | 0 | 0 | 1 (33.33%) | 1 (33.33%) | 0 | 1 (11.11%) | 1 (11.11%) | 0 |
Nausea | 1 (33.33%) | 1(33.33%) | 0 | 0 | 0 | 0 | 2 (22.22%) | 2 (22.22%) | 0 |
Hypertension | 0 | 0 | 0 | 1(33.33%) | 1(33.33%) | 0 | 0 | 0 | 0 |
Nasal congestion | 1 (33.33%) | 1 (33.33%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CRP increased | 2 (66.67%) | 2 (66.67%) | 0 | 1 (33.33%) | 1 (33.33%) | 0 | 4 (44.44%) | 4 (44.44%) | 0 |
Myalgia | 1 (33.33%) | 1 (33.33%) | 0 | 1 (33.33%) | 1 (33.33%) | 0 | 4 (44.44%) | 4 (44.44%) | 0 |
Creatinine increased | 0 | 0 | 0 | 2 (66.67%) | 2 (66.67%) | 0 | 0 | 0 | 0 |
Chills | 1 (33.33%) | 1 (33.33%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |